Kornimate/medical-research-clean huggingface dataset:
a study of tqb2450 injection in subjects with pd-l1 positive recurrent or metastatic cervical cancer

Conditions: Recurrent or Metastatic Cervical Cancer

Summary: this is a study to evaluate the efficacy and safety of tqb2450 injection in the treatment of pd-l1 positive recurrent or metastatic cervical cancer.


Eligibility criteria:
inclusion criteria: * 1. understood and signed an informed consent form; 2. eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months; 3. diagnosed as recurrent or metastatic cervical cancer; 4. has received ≥first-line platinum-containing chemotherapy, and disease progress or recur during or after treatment; 5. pd-l1 positive, and the combined positive score (cps) ≥1; 6. has at least one measurable lesion; 7. adequate laboratory indicators; 8. serum or urine pregnancy tests are negative within 7 days before randomization; men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months. exclusion criteria: * 1. combined diseases and medical history: a) has diagnosed and/or treated additional malignancy within 3 years prior to first dose;b) diagnosed as other special pathological types, such as mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumor and so on;c) unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;d) has received major surgical treatment, open biopsy and so on within 28 days before the start of the study;e) has a unhealed wound or fracture for a long time; f) has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study; g) has a history of psychotropic substance abuse and unable to quit or mental disorders; h)has any serious and / or uncontrolled disease; 2.tumor-related symptoms and treatment: a) has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study; b) has received proprietary chinese medicine with anti-tumor indications in the nmpa approved drug instructions within 2 weeks before the start of the study; c) has received immunotherapeutic drugs against pd-1, pd-l1, ctla-4 and other related drugs; d) has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; e) has symptomatic central nervous system (cns) disease and/or cancerous meningitis, pia mater disease; 3. related to treatment of research: a) has received attenuated live vaccine within 28 days before first dose or planned to received attenuated live vaccine during the study period; b) has severe hypersensitivity reactions after using monoclonal antibodies; c) has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study; d) has a history of active tuberculosis; 4.has participated in other clinical trials within 4 weeks before first dose. 5.according to the judgement of the investigators, there are other factors that may lead to the termination of the study.
march central nervous system substudy

Conditions: HIV-1 Infection

Summary: this substudy is a prospective, observational, open-label, randomised study within the march study. the purpose of this substudy is to investigate the changes in cerebral function parameters at 5 timepoints over 96 weeks of the three different treatment arms within the march study. the investigators hypothesise that there will be improvements in cerebral function in those patients randomised, as part of the parent study, into the maraviroc arms. the assessments in this cns substudy will include: 1. neurocognitive function as assessed by a computerised testing battery called cogstate; 2. changes in cerebral metabolites as measured via 1h magnetic resonance spectroscopy (1h-mrs) in those randomised to the maraviroc arms (arms 2 and 3) there is an optional lumbar puncture at week 48. the cerebrospinal fluid will be used to measure maraviroc levels and an ultrasensitive csf hiv-1 viral load. these results will be matched with levels in the plasma.

this is detailed above, this is a substudy of march

Eligibility criteria:
inclusion criteria: * provision of written, informed consent for participation in the substudy * enrolled into the substudy either at or before the week 0 visit of the main study exclusion criteria: * pre-existing cns diseases * recent head injury (past three months) * current history of major depression or psychosis

Keywords: hiv-1 infection neurocognitive function switch study
phase ii study of hmpl-004 in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: a double blind, randomized, multi-center, placebo-controlled study to evaluate the efficacy and safety of hmpl-004 in patients with active moderate crohn's disease.

this was a double-blind, randomized, multicenter, placebo-controlled study evaluating the efficacy and safety of oral hmpl-004 in subjects with active moderate crohn's disease (cd) - crohn's disease activity index (cdai) 220 to 400 - on stable doses of cd medications who had not received anti-tumor necrosis factor alpha (anti-tnf-α) for at least 3 months prior to start of treatment. hmpl-004 (or placebo) was added to the subject's existing cd medications. subjects were observed for an 8-week treatment period and a subsequent 4-week follow-up period.

Eligibility criteria:
inclusion criteria: * have active confirmed crohn's disease (confirmed radiographically, endoscopic, or histologically), with a cdai of 220-400 at baseline screen exclusion criteria: * they have received anti-tnf-α antibody within 3 months of starting study medication, or cyclosporine, tacrolimus, thalidomide or mycophenolate mofetil within 2 months of starting study medication
coping skills for alcohol use

Conditions: Alcohol Drinking; Coping Skills

Summary: a total of 120 young adults who drink to cope with negative affect will be randomized to a 4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60) or an assessment only control (n=60). participants will complete 4 weekly assessments and a 1- and 3-month follow-up.


Eligibility criteria:
inclusion criteria: - eligibility criteria at recruitment include: 1)18-25 years old; 2) currently live in the state of wa, 3) have a valid email address and phone number, 4) drank alcohol at least once in the past month, 5) report at least 1 alcohol-related problem in the past month, 6) report using alcohol to cope with distress via negative reinforcement (i.e., to provide relief or reduction of stress or depressed mood) in the past month exclusion criteria: * none
efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet-double blinded, randomized, multicenter, placebo controlled clinical trial

Conditions: Cold Hypersensitivity

Summary: to investigate the efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet


Eligibility criteria:
inclusion criteria: * female subjects aged 19 to 59 years have a complaint of chhf. * patients must include at least one or more of the following symptoms: * those who have the symptoms of chh in normal temperature which most individuals feel no cold; * those who have the symptoms of extremely cold hands in cold temperature exposure; * those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed; * those who have 4 cm or greater of vas chh score; * a thermal differences between the palm (pc8) and the upper arm (lu4) may be higher than 0.3℃; * those who can comply with all study-related procedures, medications, and evaluations; * given a written informed consent form. exclusion criteria: * patients with calcium antagonists or beta-blockers with the purpose of treating chh; * those who have one or more finger gangrene or ulceration; * those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs; * those who are diagnosed by autoimmune disease or have a positive ana test result; * those who are diagnosed by carpal tunnel syndrome or have a positive tinel and phalen's tests; * those who are diagnosed with cervical disc herniation or (malignant) tumor disease; * those who are diagnosed with diabetes; * those who are currently medicated to drugs that may affect to chh symptoms, such as anticoagulants etc; * those who have moderate level of liver dysfunction (each of ast, alt greater than 100 iu/l) or kidney dysfunction (cr 2.0mg/dl); * those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness; * those who are diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (hgb) level less than 7g/dl, hematocrit (hct) level less than 26%, white blood cell (wbc) level greater than 11,000/mm3); those whose systolic blood pressure (sbp) 180mmhg or diastolic blood pressure (dbp) is greater than 100 mmhg based on average value of at least 2 measurements; * those who are suspected arrhythmia that showing up on ecg, or diagnosed by heart diseases, such as, ischemic heart disease and so on; * those who are addicted to alcohol or drugs; * those who are pregnant (positive urine-hcg) or lactating or have the chances of pregnancy; * those who are diagnosed with malignant tumor * those who are currently participated in other clinical trials; * those who are able to understand and speak korean; * those who are judged to be inappropriate for the clinical study by the researchers.

Keywords: cold hypersensitivity korean medicine ucha-shinki-hwan
turkish isolated coronary ectasia registry: the t-ice registry

Conditions: Coronary Artery Disease

Summary: the t-ice study is a prospective, observational study aiming to have information about the treatment and long-term prognosis of patients with isolated coronary artery ectasia.

coronary artery ectasia is a localized or diffuse enlargement of the coronary artery lumen ≥1.5-2 times relative to the normal segment. it is often associated with coronary artery stenosis. some patients have coronary artery ectasia without stenosis. this condition is called as isolated coronary artery ectasia. there is data other than retrospective studies with a small number of cases on the clinical significance, prognosis and treatment of isolated coronary ectasia in patients with or without acute coronary syndrome. therefore, the treatment of patients with isolated coronary ectasia is not evidence-based and is based on the clinical judgment of physicians. the aim of this prospective observational study is to evaluate the treatment and prognosis of the isolated coronary artery ectasia. the second aim is to compare the prognosis of isolated coronary ectasia with the coronary artery disease.

Eligibility criteria:
inclusion criteria: * isolated coronary artery ectasia (without ≥20% stenosis in any coronary artery ≥2 mm in diameter). * all patients with isolated coronary ectasia with or without acute coronary syndrome will be included. * patients aged ≥18 years. * patients with discrete coronary artery aneurysm will be included. exclusion criteria: * life expectancy \<24 months * patients with ≥20% stenosis in a vessel ≥2 mm in diameter.
longitudinal and cross-sectional analysis of pulmonary microbiota in lung transplant recipients infected with nocardia

Conditions: Nocardia Infections; Lung Transplantation

Summary: this retrospective observational study aims to explore the impact of nocardia infection on the pulmonary microbiota of lung transplant recipients (ltrs). the study will analyze both cross-sectional and longitudinal data from patients diagnosed with nocardia pneumonia, comparing microbial composition and diversity between infected and non-infected groups. this research seeks to provide insights into the relationship between pulmonary microbiota alterations and clinical outcomes in ltrs.

this study is a single-center, retrospective, observational study designed to investigate the impact of nocardia infection on the pulmonary microbiota of lung transplant recipients (ltrs). the study will include both cross-sectional and longitudinal analyses. in the cross-sectional study, 17 ltrs diagnosed with nocardia pneumonia (nocardia pneumonia group, npg) will be compared with 51 non-infected ltrs (non-nocardia infection group, nnig) matched for age, sex, and underlying conditions. the longitudinal study will follow ltrs over a 4-month period, collecting samples before, during, and after treatment. patients in this group will be categorized into the recovered group (rg) or not recovered group (nrg) based on treatment outcomes. the study will also include a subgroup analysis of patients with disseminated nocardia infection, comparing pulmonary and systemic microbiota changes. microbial diversity and composition will be assessed using high-throughput sequencing of bronchoalveolar lavage fluid (balf) samples. statistical analyses will include the kolmogorov-smirnov test, anova, and kruskal-wallis test for group comparisons, with linear mixed-effects models used to analyze changes over time. the goal of this study is to provide a deeper understanding of how nocardia infection affects the pulmonary microbiota in ltrs and to identify key microbial species associated with clinical outcomes.

Eligibility criteria:
inclusion criteria: * lung transplant recipients * diagnosed with nocardia pneumonia (for the study group) * age ≥ 18 years exclusion criteria: * patients with incomplete medical records * patients who survived ≤ 3 days after transplantation * patients lost to follow-up

Keywords: nocardia; pulmonary microbiota; retrospective study; immunosuppression
pediatric multicenter study of repel-cv

Conditions: Adhesions

Summary: this trial will study repel-cv for reducing post operative adhesions following cardiovascular (cv) surgery.

- efficacy at second sternotomy

Eligibility criteria:
inclusion criteria: * stage sternotomies exclusion criteria: * delayed closure beyond 5 days

Keywords: post operative adhesions
hernia repair four arm comparative study

Conditions: Inguinal Hernia

Summary: this study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. it aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

the study compares two traditional techniques of inguinal hernia repair; namely lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. it compares the operative time, complications, postoperative pain and the speed of patient recovery.

Eligibility criteria:
inclusion criteria: * adult male primary inguinal hernia exclusion criteria: * recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]

Keywords: minimally invasive inguinal hernia pro-peritoneal repair
prolonged exposure sertraline

Conditions: Posttraumatic Stress Disorder

Summary: the current research study aims to compare the effectiveness of two proven treatments for posttraumatic stress disorder (ptsd): prolonged exposure (pe), sertraline, and their combination. in addition, the investigators are examining predictors of response to these two treatments and how ptsd symptoms, thoughts, and biological factors may be changed by such treatments. biological mechanisms of change are also examined including emotion processing and regulation in fmri, hpa axis function, and genetics and genomics. in addition, the investigators will examine acceptability of each treatment and reasons for ending treatment.


Eligibility criteria:
inclusion criteria: * patient is an operation enduring freedom/operation iraqi freedom/operation new dawn (oef/oif/ond) combat veteran with chronic posttraumatic stress disorder (ptsd) or significant ptsd symptoms (clinician administered posttraumatic stress disorder scale \[caps\] \>= 50) of at least 3 months duration exclusion criteria: * current, imminent risk of suicide (as indicated on c-ssrs) * active psychosis * alcohol or substance dependence in the past 8 weeks * unable to attend regular appointments * prior intolerance or failure of adequate trial of prolonged exposure (pe) or sertraline (sert) (defined as at least 2 months of sert at least 100mg/day) * medical illness likely to result in hospitalization or for which treatments are contraindicated (based on lab results, medical history and physical exam) * serious cognitive impairment (as evidenced by cognitive impairment felt likely to interfere with the ability to participate meaningfully in the study) * concurrent antidepressants or antipsychotics * pregnant females

Keywords: combat-related ptsd posttraumatic stress disorder prolonged exposure therapy sertraline military veterans va hospital mental illness
non-interventional observational study with viramune plus antiretroviral in hiv infected patients

Conditions: HIV Infections

Summary: this observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with viramune (nevirapine) in combination with arv, e.g. combivir (zidovudine and lamivudine), kivexa (abacavir and lamivudine) or truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (hiv-rna below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of viramune (nevirapine) and arv, e.g. combivir (zidovudine and lamivudine), kivexa (abacavir and lamivudine) or truvada (tenofovir and emtricitabine).


Eligibility criteria:
inclusion criteria: * male and female * 18 years or older * written informed consent * the inclusion criteria for treatment with viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / smpc exclusion criteria: * pregnant patients * the exclusion criteria for the treatment of viramune plus other antiretroviral combination drugs are to be based on the current smpc
a retrospective study of reco thrombectomy stent for intravascular treatment of acute ischemic stroke

Conditions: Neurology; Interventional Therapy

Summary: to explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. to investigate the use and embolectomy effect of reco, the first embolectomy stent in china, in economically developed areas. health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.

the reco embolectomy stent is indicated for patients who cannot be treated with intravenous tissue activator (ivt-pa) or who have failed ivt-pa therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.

Eligibility criteria:
inclusion criteria: * patient age ≥18 years * the clinical diagnosis was acute ischemic stroke * large vascular lesions were detected by head ct, cta, mri, mra or dsa * preoperative baseline nihss score \> 4 * mrs 0-1 before this stroke * mechanical thrombectomy was performed * use reco thrombectomy bracket exclusion criteria: * epileptic seizure * sudden coma * neurological loss symptoms quickly improved * imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage * previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect) * history of head trauma within 3 months prior to surgery * history of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery * physical examination revealed evidence of active bleeding or trauma (e.g. fracture) * women are known to be pregnant or breastfeeding * severe allergies to contrast agents are known

Keywords: ischemic stroke reco endovascular treatment
effect of extubation under deep anesthesia on emergence agitation of nasal surgery

Conditions: Emergence Agitation

Summary: this study analyzed the relationship between extubation timing and emergence agitation in 18-60 years old adults undergoing nasal surgery, such as nasal septum correction, endoscopic sinus surgery, and nasal bone fracture reduction. the number of agitation, sedation score, pain score, operation method, analgesic drugs and other data were recorded to analyze the effect of deep anesthesia extubation on agitation in patients with nasal surgery. it also provides a clinical basis for the prevention and treatment of agitation during the recovery period of such operations in adults.

nasal surgery is an operation with a high proportion of pain and agitation found in the clinical medical treatment of our hospital. although the operation time is short, the operation trauma is small, and it does not involve important organs and blood vessels, the clinical observation shows that the incidence of agitation in such patients after operation is high, and the degree of pain varies greatly. many studies have analyzed the related risk factors of agitation in the wake-up period of adult nasal surgery, and believe that the existence of postoperative endotracheal tube is the main risk factor. however, there is a lack of prospective randomized controlled study on the timing of postoperative extubation in patients with nasal surgery. therefore, this study analyzes the impact of extubation timing on postoperative agitation, so as to clarify the correlation between postoperative agitation and extubation timing and possible protective factors, which is helpful to early prediction, prevention and treatment, and reduce the incidence of postoperative ea in patients with nasal surgery.

Eligibility criteria:
inclusion criteria: asa grade i-ii age 18-60 patients undergoing selective general anesthesia for the correction of septum, endoscopic sinus surgery, bone fracture reconstruction, resection of sinus tumor, augmentation of nose and other nasal surgery subjects voluntarily participate in the study and sign informed consent exclusion criteria: history of mental and neurological diseases; history of chronic pain or long-term use of opioids and other analgesics; history of respiratory diseases, severe pulmonary dysfunction and airway hyperresponsiveness; history of severe hypertension and cardiovascular disease; pregnant women; patients with severe primary diseases such as liver, kidney and hematopoietic system; patients with abnormal liver function (alt, ast and tbil exceeding 1.5 times the upper limit of normal value) or renal dysfunction (creatinine and urea nitrogen exceeding 1.5 times the upper limit of normal value) history of alcohol or drug abuse; history of epilepsy or a recent epilepsy; obese patients, bmi ≥ 30kg / m2, or with sleep apnea; in addition to the above, the researchers judged that they were not suitable to participate in this clinical trial.